Report shows how the FDA incorporates the two ISO standards in its medical device development policy, how the EU version of the two standards differs in significant ways and how the EU Medical Device Regulation may require further changes in the European standards.
Australia’s drug regulatory agency is urging drugmakers to reassess their quality control and data management systems after agency officials found frequent data integrity violations during GMP inspections over the past five years. Read More
GMP woes for foreign and domestic facilities continued as the FDA issued three warning letters to Indian and Chinese factories as well as a U.S. facility over data integrity and quality control problems. Read More